Combined fine-needle aspiration, physical examination and mammography in the diagnosis of palpable breast masses: their relation to outcome for women with primary breast cancer.

Objective: To examine the combined and individual predictive values of fine-needle aspiration (FNA), physical examination (PE) of the breast and mammography (the "triple test") in diagnosing breast cancer in relation to the results of open surgical biopsy.

Design: A study of the records of patients who received both FNA and open surgical biopsy for the same palpable breast lump. The results of diagnostic assessment and open surgical biopsy were categorized as positive or negative. Concordance (percentage of tests found to be correct at biopsy), sensitivity, specificity (percentage of patients without breast cancer for whom the diagnostic test was negative) and positive predictive value (percentage of patients with a positive test found to have breast cancer) were determined for the triple test for each diagnostic modality. In addition, prognostic variables (tumour size, node positivity, estrogen and progesterone receptor status) and outcomes were assessed in patients with a diagnosis of breast cancer.

Setting: A university-affiliated general hospital with a special focus on women's health.

Patients: Of 290 patients who had both FNA and open surgical biopsy, 191 underwent all three diagnostic procedures.

Main Outcome Measures: The diagnostic accuracy of FNA, PE and mammography to permit preoperative definitive therapy or to allow observation without mandating open surgical biopsy.

Results: In 81 patients all three diagnostic modalities were in agreement for a diagnosis of either benign or malignant disease; the concordance for the triple test was 98.8% specificity was 100% and sensitivity was 95.5%. Nodal status, tumour size and outcome were similar whether or not the triple test was positive, but, interestingly, when the triple-test results were positive, estrogen (p < 0.05) and progesterone (p < 0.03) receptor values were more likely to be negative.

Conclusions: When all three diagnostic modalities were in agreement for a diagnosis of malignant disease, the combination of FNA, PE and mammography had excellent concordance with the results of open surgical biopsy, and in this situation definitive treatment may be carried out. If all three modalities are in agreement for a diagnosis of benign disease, a period of close observation with repetition of FNA may be safely entertained. Lack of concordance of the three diagnostic modalities mandates biopsy. Triple-test positively does not predict a worse outcome.